• TGA’s Amendments to TGO 91, and 92. What Should You Decode?

    October 10, 2017
    Regulatory Labeling
    Health Authority Updates
    TGA’s labeling Amendments to TGO 91, and 92

    Since 31st August 2016, the Therapeutic Goods Administration (TGA) is continuously working to update its guidelines for labeling of medicines supplied in Australia to ensure companies be aligned with international labeling best practices and reduce medication errors. As part of the ongoing changes, following the recent updates in August, the Australian Health Authority, post consulting different stakeholders and decoding their views, has announced few amendments to the new labeling orders.

  • Regulatory Labeling Services

    Freyr offers end-to-end drug Regulatory labeling services and software support for global and regional Regulatory labeling management, providing professional assistance in drafting Investigational Brochures (IB), Developmental Core Data Sheets, and Developmental Core Safety Information, creating and updating Company Core Data Sheet (CCDS), core to local product labeling requirements, etc.

  • End-to-End Regulatory Services

    Overview

    The Life Sciences market is growing and is expected to reach US$ 4,200 Million by the end of 2024. At the same time, the world is turning more protective about increasing health concerns. Alongside addressing the health needs and aligning with the market scenario, the pharma, biotech, cosmetic, medical devices and healthcare organizations shouldn’t only innovate new compliant products, but also ensure that they are accessible across the globe with stringent safety and efficacy measures.

  • Food/Dietary Supplements Labeling

     

    Food Supplements Labeling - Overview

    With modern society becoming increasingly focused on healthy eating, food supplement labeling helps the consumer to make an informed decision. In its simplest form, a food label or dietary supplement label communicates the existing product information to the customer, thus assisting him in understanding the key ingredient, nutritional and safety information he needs to know about the product.

  • Pharma Labeling Compliance

     

    Pharma Labeling Compliance Services: Overview

    Labeling is an interdisciplinary function that serves as the basis for prescribing information, advertising, and promotional materials for medication. Biopharmaceutical product labeling is a complex process that involves multiple products and markets for different formulations and dosages, maintaining pharma labeling compliance throughout the process.

  • Regional Labeling - Europe

     

    EU Labeling Services : Overview

    For medicines, EMA and various other national medicine evaluation agencies require that certain documents, including the Summary of Product Characteristics (SmPC), the Patient Information Leaflet (PIL), and the packaging and labeling texts, be presented in the official language or languages of the Member States or markets in which the medicinal product is to be placed.

  • Regional Labeling - USA

     

    FDA Drug Labeling Services: An Overview

    To help clients meet US labeling requirements, Freyr's specialized regional labeling service involves converting current labeling content into the required Structured Labeling (SPL) format, while adhering to Physician Labeling Rule (PLR) Compliance and Drug Registration and Listing. This process involves a comprehensive review and careful reformatting of the information to fit the structured requirements outlined by the FDA.

  • Regional Labeling Services

     

    Regional Labeling Services : Overview

    Product labeling is designed to serve multiple functions across several regions and countries through regional labeling services. On a basic level, national and regional Health Professionals (HP), patient, and consumer labeling communicate information about the benefits and risks of the product. It also offers advice on the effective and safe use of the same product.

  • Global Labeling Services

     

    Global Labeling Services : Overview

    As a critical aspect of product lifecycle management, global labeling is one of the complex processes of the life sciences’ Regulatory environment. Due to constantly evolving Regulatory labeling requirements, organizations must ensure that the product information related to manufacturing, safety, and efficacy mentioned on the core labels is controlled by maintaining central or core reference product information.

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